Director of Regulatory Affairs
The Director of Regulatory Affairs is responsible for defining and implementing regulatory strategies to obtain global approvals of new/modified devices and combination products in order to support meeting Anika’s business objectives.
Strategic Focus Areas:
The role of Director of Regulatory Affairs requires the ability to analyze complex technical and medical information and formulate strong regulatory arguments that can be defended with regulatory agencies such as the FDA and international Health Authorities. The individual must also ensure compliance with global regulations for design controls, cGMP, facility registration, device listing, licenses, safety reporting, complaints, clinical trial requirements, post-market surveillance, labeling, and permissible marketing communication. This position reports to the VP of Regulatory/Clinical Affairs. The Director of Regulatory Affairs manages a staff of Regulatory Affairs professionals in the U.S.
Specific Tactical Responsibilities:
- Work closely with Marketing, R&D, Manufacturing, and Clinical Affairs, develop the regulatory strategy to gain market approval for new or modified devices/combination products consistent with corporate objectives.
- Lead the preparation of complex submissions including PMAs, NDAs, BLAs, 510(k)s,
- INDs, IDEs, Notified Body/Competent Authority application, Health Canada licenses, and submissions to other international Health Authorities.
- Interact proactively and persuasively with global regulatory agencies in order to gain approvals.
- Ensure clinical studies are designed and executed in full compliance to GCP, ICH, and pertinent global regulations.
- Provide oversight of regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted.
- Ensure product labeling and promotional materials are compliant with regulations.
- Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance.
- Possesses in-depth understanding of US and OUS regulation requirements. Actively reviews new laws/regulatory requirements to maintain proficiency in worldwide regulations and communicates pertinent information.
- Responsible for global safety reporting and complaint handling in accordance with regulations.
- Hire, manage, and develop staff of regulatory professionals in the U.S.
- Contract and manage specialized regulatory consultants as necessary.
- Accountable for developing and meeting regulatory timelines and budgets.
- Represent Anika during audits by regulatory agencies.
Position requires a high level of critical and creative thinking. Individual must have a strong handle on US and OUS medical device and drug regulation.
Manage Regulatory staff and consultants
Bachelor’s degree, preferably in life sciences or related field
Desired Experience, Knowledge, and Skills:
- BA/BS in the life sciences, or engineering with MS preferred
- Requires 10+ years of regulatory experience in the medical device/pharmaceutical/biologics industry.
- 5+ years of managerial experience required including direct supervisory experience and experience building/meeting budgets and timelines.
- Requires experience developing and successfully defending complex regulatory submissions for medical devices (PMA, 510(k), IDE) and combination devices (IND, NDA).
- Requires experience directly, and successfully, interfacing with the FDA and other regulatory bodies.
- Experience with international device and drug regulatory submissions required, including EU, Health Canada, kFDA, and other ROW health authorities.
- Requires strategic leadership, strong communication and persuasion skills, and the ability to craft strong regulatory arguments.
- Strong project management and problem-solving skills
- Regulatory Affairs Certification preferred